Senior Auditor, Quality Assurance

Job Description
The Senior Auditor, Quality Assurance role is a senior role that effectively manages and conducts internal and contracted audits for the Company and for Company’s Clients. The role provides input into audit strategy and risk-based audit planning and leads process and complex audits, as well as providing QA consultancy activities within their area of GxP expertise.
Core responsibilities of the Senior Auditor are:

Auditing

Within area of their GxP expertise, conduct audits initiated by the Company, or contracted by small to mid-size Clients, according to the agreed Audit Program including effective management of pre-audit activities.

Audit types may include:

Audits of Company Partners and Vendors/Service Providers

Internal System Audits

Study audits (e.g. of study files, investigational sites)

Audits of Third Parties on behalf of Clients (e.g. including MAH PV System, Vendors, MAH Affiliate/ Partner Audits).Reviews and approves all final CAPA plans from contracted audits within timelines mandated by Company/ Client procedures

Consultancies e.g. Client PV / QMS system gap analysis, SOP development, etc.

Main QA contact for designated Clients and plans, conducts and reports on audits requested by Clients

Quality as a Service
Attend commercial meetings related to Quality as a Service

Supports Clients with a wide variety of Quality as a Service activities, including
Mock inspections

Training

Gap analysis

Procedure drafting and revision

Other
Supports audits and inspections of the Company performed by Clients/third parties and regulatory authorities

Works with the Quality leadership to develop and train Auditors and other quality employees

Assists in the development of strategic internal audit program

Maintain an up-to-date knowledge of international regulatory requirements, guidelines and best practices and actively participate in knowledge-sharing and learning process to ensure personal and team continuous learning and development

Participate in preparation (authoring or QC) of audit strategy, SOPs, guidelines and other documented procedures required for auditing activity of the Company and/or Client as per operational needs

Bachelor’s degree in a scientific discipline required; Master’s degree preferred, or equivalent relevant industry experience.

Experience

Strong previous pharmaceutical and/or biotech pharmacovigilance experience, including strong understanding of GVP & GCP related Quality Management and Assurance, with previous experience of GVP and GCP auditing experience in an Audit Lead role.

Analytical, written and oral communication skills

Ability to manage all tasks assigned and effectively deliver all expected deliverables in an organized and a timely manner

Proactively communicate changes in pre-established goals and deadlines

Ability to think strategically and to work collaboratively using risk-based, proactive approaches to problem-solving

Strong team player

Fluent in English (written and spoken); additional/ local languages a plus, but not required

When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.
We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.
Quality: we hold ourselves to the standard patients deserve.

Integrity and trust: we do the right thing, especially when it is hard.

Drive and passion: we care about the outcome, because someone is waiting on it.

Agility and responsiveness: we move quickly, because patients cannot wait.

Belonging: everyone is welcome, and every voice counts.

Collaborative partnerships: we go further by going together.

We look forward to welcoming your application.
Medicine moves forward here. So will you.
Clinical trials, safety studies, and audits make safe and innovative pharmaceutical-led care possible. As part of Ergomed Group, you help patients benefit so they experience more of life’s meaningful moments. Biopharmaceutical companies are our clients. Patients are our purpose.
Ergomed Group brings together Ergomed CRO, PrimeVigilance, Prudentia, and ADAMAS Consulting to help biopharmaceutical companies develop, deliver and safeguard therapies in oncology, rare disease and other complex areas of medicine. Across the Group, our teams turn the signals that clinical trials, safety systems and quality data generate into insight that helps bring safer treatments to patients around the world.
The science and analysis that guides our work is demanding. And this is where we excel. What defines us, though, is how we work together. Across countries, cultures and time zones, we bring kindness, curiosity and a shared sense of purpose to work that genuinely matters. Ideas are welcome here. Growth is expected. And every person has room to make a real difference to patients' lives.
Whether you are early in your career or bringing decades of experience, we want you to feel valued for what you do and for who you are. If that sounds like the place you have been looking for, we would love to hear from you.
Originally posted on Himalayas